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Full Steam Ahead On Medtech Value-Based Business Models

Federal health-care policy in the US, at least, is potentially in for a major transition, but that is not having much of an impact on the fundamental business models of medtech firms and their ever-accelerating focus on value-based and risk-sharing business models. Emphasis on value strategies was a significant medtech theme at this year's JP Morgan Healthcare Conference bonanza.

Commercial Reimbursement Medical Device

US Approvals Analysis: 2016 Another Record Year For FDA Novel Device Approvals

The agency approved a total of 91 original PMAs, panel-track PMA supplements and de novo classifications in 2016, outpacing last year's record for approvals of novel devices or indications, according to Medtech Insight's Approvals Tracker. Medtronic topped both the novel device approvals and 510(k) clearance lists for the year. Roche, Abbott, Siemens and GE also showed strong approval and clearance counts.

Approvals Research & Development Medical Device

Do Hill-Rom, PerkinElmer, Integra Deals Signal 2017 M&A Acceleration?

The second week of 2017 scored a hat trick of M&A deals, including Hill-Rom's $330m acquisition of a privately held diagnostic cardiology and patient-monitoring company. This deal builds on the diagnostics and monitoring product lines Hill-Rom established when it acquired Welch Allyn in 2015.

M & A Surgery In Vitro Diagnostics

Device Week – Jan. 13, 2017

A big JP Morgan meeting in San Francisco, possible repeal of the Obamacare medical device tax, a record-breaking False Claims Act settlement, and a new combination products guidance were the topics of this week's Medtech Insight podcast.

Medical Device Policy Regulation
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HHS Nominee Price's Stock Picks To Surface At Confirmation Hearings

Questions about US Health and Human Services Secretary nominee Tom Price's investments over the last year – including in Zimmer Biomet – and overlapping legislation he has introduced are likely to be raised at confirmation hearing before the Senate HELP Committee this week. However, Zimmer Biomet and other device firms have been trying to profit from the business models that Price opposes.

Policy Legislation United States

UK Medtechs Look On As Prime Minister Sets Firmer Course To EU Exit

UK Prime Minister Theresa May delivered a speech Jan. 17 that finally gave some substance to her oft-ridiculed assertion that "Brexit means Brexit." There were few surprises, but to the delight of medtech stakeholders, medical devices were referenced, albeit fleetingly.

Brexit Medical Device United Kingdom

Dexcom First To CGM Reimbursement Finish Line

Following a recent approval for their G5 continuous glucose monitor for use in children and adults without a finger stick, Dexcom has scored big with a new US Centers for Medicaid and Medicare Services policy that would make their CGM the first of its kind eligible for reimbursement from the agency.

Medicare Reimbursement

Warning Letter Roundup & Recap – Jan. 17, 2017

No device-related warning letters were released by US FDA the week of Jan. 17.

Device Warning Letters Policy & Regulation

2017: Year Of The New EU Medtech Regulations: But Is EU Ready?

2017 is going to be a pivotal year for EU medtech regulations. We are expecting the new Medical Devices Regulation and IVD Regulation to take effect. But there are some big concerns and uncertainties at the center of it all.

Medical Device Policy & Regulation

Top EU Regulatory and Political Tweets in 2016

What were the main concerns for the medtech sector in 2016 when it came to following EU medtech regulatory and political tweets?

Medical Device Diagnostics

Stay Of Execution In EU For Environmental Shortfall Devices

It now looks as if some refurbished and second-hand electronic devices may continue to be supplied and resold on the EU market before the mid 2019 deadline that had previously been agreed.

Regulation Europe

Medtech Guidance Tracker: December 2016

Stay up-to-date on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. In the latest update, see documents posted in December 2016.

Regulation Medical Device

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Shire To Pay Record-Setting Device FCA Settlement

The $350m settlement resolves False Claims Act allegations Shire and its subsidiaries used tactics including lavish meals, free medical equipment, unearned speaker payments and cash to encourage doctors to prescribe the company’s Dermagraft human skin substitute.

Legal Issues Commercial Wound Healing & Tissue Repair

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US Sales Of Sinclair Pharma's Silhouette InstaLift-Off

Aesthetics company Sinclair Pharma has reported headline growth of 51% in 2016 due to strong unexpected interest for its Silhouette Instalift product.

Aesthetics Sales & Earnings

Zimmer Biomet To Settle Overseas Bribery Charges With US DOJ

The orthopedic device company is set to pay $17.4m to the US Department of Justice and an additional $13m to the Securities and Exchange Commission to resolve allegations that Biomet didn’t stop corrupt acts in Brazil and Mexico even after a 2012 deferred prosecution agreement.

Legal Issues Medical Device

IBM Digs Deeper Roots In Medtech, As AdvaMed Builds Digital Footprint

IBM is getting more heavily invested in the medical device industry, announcing two major partnerships this week with diagnostic-maker Illumina and US FDA. The move is part of a larger industry trend of tech firms becoming more active in the medtech sector, and AdvaMed is adjusting to the new context.

Business Strategies Commercial

Turkish Hospitals' Billion-Dollar Debt A Top Priority For Medtech Suppliers

While many medtech companies are looking at strategies to grow their sales this new year, those that are operating in Turkey look like their focus would be on simply getting paid for what is owed by the country's debt-ridden hospitals.

Turkey Policy

VC Deals Analysis: 2016 Bucks The Trend As Investment Dollars Dip

2016 was the year to break the bull run in venture investment activity, with total deal value and volume failing to surpass that of 2015. However, the IVD sector continued to be the most popular area for investment, and technologies that can help unravel the genomic puzzle behind diseases like cancer were the ones that attracted the big bucks last year and look likely to remain so in 2017.

StartUps and SMEs Financing

Philips, Illumina Sign Genomics For Cancer Pact

Philips and Illumina are teaming up to develop a connected solution for the analysis and interpretation of genomic information in cancer.

In Vitro Diagnostics Cancer

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OUS Approvals Analysis: Slow Finish To 2016, But Still Ahead Of 2015

2016 finished with just two more non-US medical device approvals than 2015; December was by far the slowest month of the year for approvals from outside the US with just 11.

Approvals Europe Asia Pacific

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Philips Shooting For Spine Surgery Top Spot With Augmented Reality Tech

Philips is developing what it claims to be the first augmented reality surgical navigation technology that enables surgeons to view a patient's external and internal anatomy in real time during minimally invasive spine surgery. The Dutch group believes this technology could earn it a top spot in the spine surgery market.

Surgical Procedures Innovation

Infographic: 2016 Medical Device Approvals

Here's a graphical look at the global device approvals in 2016. It was another record year for novel devices in the US, while trends remained relatively steady in other regions.

Approvals Research & Development

First TAVR Filter Gets US FDA Panel Date

Claret Medical’s Sentinel CPS missed its primary endpoint during a pivotal trial but showed greater benefits for patients receiving Sapien XT valves, and affirmed that it trapped debris and had a clinical benefit.

Cardiovascular Policy & Regulation

Starts & Stops: S-ICD And Respiratory App Studies Among Year-End Large-Scale Trial Launches

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions over the past month. This edition notes the particularly high number of large-scale trials launched toward the end of 2016.

Clinical Trials Research & Development

Start-Up Spotlight: Apama Medical, Targeting AFib With An RF-Balloon Combo

Founded and led by serial entrepreneur Amr Salahieh, Apama Medical is developing a system that aims to combine the advantages of two approaches for treating atrial fibrillation: point-by-point radiofrequency-based ablation and cryoballoon ablation.

Cardiology Innovation

Abbott Highlights Predictive Potential Of Troponin Testing

Findings from the WOSCOPS trial indicate that high-sensitivity cardiac troponin testing may be able to identify patients at greatest risk of future coronary events and to assess their response to preventative interventions, including statins.

In Vitro Diagnostics Cardiology
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